Clinical Trial of the Neoadjuvant Standard Chemotherapy 3 FEC 100 + 3 TAXOTERE Protocol Versus the Same Protocol Adapted as a Function of Clinical Response
- Patient with histological proof of non metastatic breast cancer, whose clinical tumor
diameter is > 2 cm, or < 2 cm, but situated in areolar area of the nipple.
- T2-T3, N0-N1 tumor, non-inflammatory, unilateral, non-metastatic, grade II – III,
HER2-neu negative, without extension beyond the breast and axillar area.
- Performance Status = 0-1 WHO.
- Patient non pretreated for breast cancer.
- Patient without cardiac pathology and without anthracyclines contra-indication
(assessed by normal ejection fraction).
- Normal haematological, renal and hepatic functions : PNN > 2.109 /l, platelets > 100.
109 /l, Hb > 10 g/dl, normal bilirubin serum , ASAT and ALAT < 2,5 ULN, alkaline
phosphatases < 2,5 ULN, creatinin < 140 µmol/l or creatinin clearance > 60 ml/min
- Written informed consent dated and signed by the patient
- All other breast cancers than those described in inclusion criteria, in particular
inflammatory and/or neglected (T4b or T4d) forms.
- Patient presenting with plurifocal tumors, multicentric tumor, bilateral tumor.
- Grade I well differentiated tumor.
- HER2 neu 3 + (ICH or FISH or CISH) tumor.
- Non measurable lesion, in the two diameters, whatever radiological methods used.
- Patient presenting microcalcifications for which breast conservation is not possible.
- Patient already operated for breast cancer or having had primary axillar node
- Patient having antecedent of other cancer, exception for in situ uterine cervix or
basocellular skin cancer, considered as healed.
- Patient presenting another pathology considered as incompatible with patient
inclusion in the study
- Patient should not receive treatment with any other investigational drug and should
not participate to another clinical study in a delay < 30 days or should not be
pre-treated by cytostatic chemotherapy.
- Antecedents of allergy to polysorbate 80.
- Patient who is pregnant or lactating and not using effective contraceptive method.
- Any psychological, familial, sociological or geographical condition that may
potentially hamper compliance with the study protocol and follow up schedule,
assessed with the patient prior to registration in the trial